FDA Enforcement
Class II
Terminated
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.
Recall: Z-0937-2015
·
Reported January 14, 2015
Enforcement
- Recall Number
- Z-0937-2015
- Event ID
- 69979
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 14, 2015
- Initiation Date
- December 4, 2014
- Classification Date
- January 7, 2015
- Termination Date
- July 28, 2015
- Address
- 45 Great Valley Pkwy, N/A, Malvern, PA, 19355-1302, United States
Description
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.
Reason
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
Code Info
all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.
Distribution
Worldwide Distribution: US (nationwide) and country of: Canada.
Quantity
2155